The Study Of Fluconazole For Vulvovaginal Candidiasis
Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vulvovaginal Candidiasis
Intervention: Fluconazole (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
As for the indication of vulvovaginal candidiasis, a single oral administration of
fluconazole 150 mg has been approved and is recommended by guidelines overseas. However in
Japan oral therapy with antifungal triazole such as Fluconazole has not been approved, and
topical therapies such as vaginal tablets, pessary and cream are used clinically. The
purpose of this trial is to confirm the efficacy and safety of single oral administration of
fluconazole 150 mg for the treatment of vulvovaginal candidiasis in Japanese patients.
Clinical Details
Official title: A Multicenter Open-label Non-comparative Study Of Fluconazole For The Treatment Of Vulvovaginal Candidiasis.
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Therapeutic Outcome: Response RateArea Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid
Secondary outcome: Clinical Efficacy: Cure RateClinical Efficacy: Cure and Improvement Rate Mycological Efficacy: Eradication Rate Total Scores for Clinical Symptoms Maximum Observed Plasma Concentration (Cmax) Time to Reach Maximum Observed Plasma Concentration (Tmax) Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast) Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Patients with clinical symptoms and signs of vulvovaginal candidiasis.
- Patients tested positive for Candida by fungal culture.
- Patients who can agree not to have intercourse up to 28 days after dosing.
Exclusion Criteria:
- Patients with a history of hypersensitivity to fluconazole.
- Patients with severe renal dysfunction.
- Patients with liver disorder.
Locations and Contacts
Mori Ladies Clinic, Fukuoka 810-0011, Japan
IZUMI Ladies' Clinic, Gifu 502-0914, Japan
Tetsu-Nakamura Obstetrics and Gynecology Department Internal Medicine, Kagoshima 892-0845, Japan
Women's Clinic Kamimura, Okayama 700-0901, Japan
Hayakawa Clinic, Osaka 542-0086, Japan
Sutou Ladies Clinic, Osaka 542-0081, Japan
Ai WOMEN'S CLINIC, Asahikawa, Hokkaido 070-8003, Japan
Shirokane Ladies' Clinic, Minato-ku, Tokyo 108-0071, Japan
Takane Medical Clinic, Shinagawa-ku, Tokyo 140-0013, Japan
Suzuran Clinic, Suginami-ku, Tokyo 167-0051, Japan
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: March 2013
Last updated: December 1, 2014
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